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EMA approval · 2025-05-12

EMA Authorised: Xyrem (sodium oxybate) — UCB Pharma Ltd

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Summary

The European Medicines Agency authorised Xyrem (sodium oxybate) for cataplexy and narcolepsy. The marketing authorization holder is UCB Pharma Ltd.

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Diseases / indications

Drugs mentioned

  • Xyrem (Sodium Oxybate)

Snippet

Status: Authorised. Therapeutic area: Cataplexy;Narcolepsy. MAH: UCB Pharma Ltd. Decision date: 12/05/2025